Non-Inferiority Quantitative Transmission Ultrasound Case Collection Study
Completed
Conditions studied: Mass Lesion
In brief
Conduct a case collection study of breast imaging examinations from women with mammographically-detected breast lesions for the purpose of conducting subsequent Reader Studies.
Key facts
- Study ID
- NCT02133417
- Run by
- QT Ultrasound LLC
- People needed
- 287
- Starts
- 2014-07-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2018-05-09
Who can join
Age: 25 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female
- Age 25 or older
- A bra cup size of A through DDD
- Willing and able to provide written, signed Informed Consent Form (ICF) after the nature of the study has been explained, all questions have been answered, and prior to any research-related procedure(s)
- Willing and able to comply with all study procedure(s), including possible aspiration for a simple cyst
- Complete digital mammography views Craniocaudal and Medio-lateral Oblique (CC and MLO) for one or both breasts
- Mammographically-detected lesion(s) seen on at least one mammographic view and a corresponding HHUS correlate(s)
You may not qualify if…
- Does not meet all Inclusion Criteria
- Currently breastfeeding
- History of breast cancer in the past 12 months, except for Fine Needle Aspirations (FNA) or Cyst Aspiration
- History of breast surgeries or interventional breast procedures in the past 12 months
- Normal mammogram at the time of this evaluation
- Physical inability to tolerate the procedure on the scanner, i.e. inability to lie prone and still for up to 30 minutes at a time
- Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the scanned breast
- Breasts too large for scanner, i.e. bra size larger than DDD or inability to successfully "fit" breast after the subject is placed on scanner
- Body weight greater than 400 lbs. (180 kg)
- Has a concurrent disease or condition which in the judgment of the principal investigator disqualifies the subject, from participating in the study
Where it is running
- George Washington University Medical Center — Washington D.C., District of Columbia, United States
- Elizabeth Wende Breast Care, LLC — Rochester, New York, United States
Full record on ClinicalTrials.gov
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